| Device Classification Name |
Alloy, Amalgam
|
| 510(k) Number |
K951663 |
| Device Name |
TYTIN R |
| Applicant |
| Kerr Corporation (Danbury) |
| 1332 S. Lone Hill Ave. |
|
Glendora,
CA
91740
|
|
| Applicant Contact |
JEFFREY A ANDERSON |
| Correspondent |
| Kerr Corporation (Danbury) |
| 1332 S. Lone Hill Ave. |
|
Glendora,
CA
91740
|
|
| Correspondent Contact |
JEFFREY A ANDERSON |
| Regulation Number | 872.3070 |
| Classification Product Code |
|
| Date Received | 04/10/1995 |
| Decision Date | 06/06/1995 |
| Decision |
Substantially Equivalent
(SESE) |
| Regulation Medical Specialty |
Dental
|
| 510k Review Panel |
Dental
|
| Type |
Traditional
|
| Reviewed by Third Party |
No
|
| Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
| Recalls |
CDRH Recalls
|
|
|